The NDA for prasugrel, a treatment for patients with acute coronary syndrome being managed with percutaneous coronary intervention (PCI), has received priority review status from the FDA. Prasugrel, submitted by
Daiichi Sankyo Co. and
Eli Lilly, is likely to receive notice of action within six months of its Dec. 26, 2007 submission date.
"We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with the agency as it continues its review process," said Dr. J. Anthony Ware, Lilly vice president for cardiovascular/acute care.
"If approved, prasugrel will provide physicians and acute coronary syndrome patients an alternative medicine that may further help reduce the risk of heart attacks," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Co., Ltd.
Prasugrel could be positioned as a competitor to Plavix, which is marketed by
Bristol-Myers Squibb and
Sanofi-Aventis.
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